The Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Atropium/Albuterol in Patients COPD

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title: Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Ipratropium/Albuterolin Chinese Patients With Moderate-to-severe COPD.

Status Recruiting

Clinical Trial Summary

To determine the efficacy and safety of Salmeterol/Fluticasone Propionate 50/500ug BID vs Ipratropium/Albuterol 36/206ug QID in Chinese patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD).

Clinical Trial Description

• This is a 12-week, multicentre,randomized,open-label,active-controlled, paralleled-group study.

• Chinese patients aged ≥40 years with moderate-to-severe COPD are eligible for this study.

1. If satisfying the entry criteria, patients enter an 8 to 14 day run-in period,and replace previous bronchodilators with inhaled or nebulized Salbutamol.

2. Patients record daily severity ratings for daytime symptoms of shortness of breath, tiredness, activity limitation, frustration with symptoms, and night-time sleep symptoms on daily cards.

3. Each symptom is rated using 0-100 visual analog scal (VAS). For overall assessment of daytime symptoms, a combined symptom score is obtained by adding VAS scores for shortness of breath, tiredness, activity limitation, frustration with symptoms.

4. Patients are required to be symptomatic as demonstrated by a combined daytime symptom score of 120 on at least 4 of the 7 days prior to randomization.

1. Eligible patients will be randomized (1:1) to the following 2 treatments for 12 weeks.

1. Inhaled Salmeterol/Fluticasone propionate 50/500ug twice daily or inhaled IB/ALB 36/206ug QID.

2. Salbutamol will be provided for relief of symptoms on an "as required" basis during the whole 12 weeks.

2. A Follow-up visit will be conducted 2 weeks after completion of treatment/early withdrawal to assess for any adverse effects after discontinuing study treatment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

• NCT number: NCT01243788
• Study type: Interventional
• Source: Fudan University
• Contact: Yutong Y GU, Doctor
• Phone: 8621-64041990
• Email: gu.yutong@zs-hospital.sh.cn
• Status: Recruiting
• Phase: Phase 4
• Start date: July 2009
• Completion date: October 2011